Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer

ImaginAb

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Prostate Cancer

Treatments: Biological: [89Zr]Df-IAB2M

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923727

002-2012

Details and patient eligibility

About

This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.

Full description

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.

Enrollment: 38 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male >/= 18 years of age

• Patients with histologically confirmed prostate cancer

• Progressive disease manifest (within 6 weeks of screening) by either

  • imaging modalities (bone scan, MRI or CT) OR
  • biochemical progression (PSA)

• Performance status of 60 or higher on Karnofsky scale

• Subject's schedule permits compliance with all study procedures

• Ability to understand and willingness to sign a written informed consent form

Exclusion criteria

• Previous anaphylactic reaction to huJ591 antibody or FDG imaging
• On any new anticancer therapy (GnRH analog allowed) while on the study
• Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
• Renal lab values: Creatinine > 1.5 ULN
• Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

[89Zr]Df-IAB2M

Experimental group

Description:

A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).

Treatment:

Biological: [89Zr]Df-IAB2M